Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia

Postoperative Complications Clinical Trial

Official title:

Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103528
• Other study ID #: HHT
• Status: Completed
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: September 2019
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the effects of morning surgery with afternoon surgery on early postoperative sleep function and postoperative recovery under general anesthesia.

Description:

The circadian rhythm is an intrinsic timing mechanism generated by endogenous systems to adapt to the external environment, which is closely related to the human sleep-wake cycle. Patients after major surgery are prone to changes in sleep structure and sleep quality, called postoperative sleep disturbances (POSD), which are characterized by the total sleep time reduced, rapid eye movement sleep absent, slow wave sleep shortened, and shallow sleep phase increased, times of wakefulness increased, and highly fragmented sleep. Some studies have shown that POSD can aggravate postoperative pain and fatigue, increase postoperative delirium, cardiovascular adverse events, and even cause accidental death of patients. The investigators don't know whether the early postoperative sleep function and postoperative recovery quality of patients undergoing general anesthesia are affected by surgery in the morning or in the afternoon. The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the effects of morning surgery with afternoon surgery on early postoperative sleep function and postoperative recovery under general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 25, 2019
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. aged 18-60 years old.

2. ASA status I or II.

3. BMI 18.5-28 kg/m^2.

4. performed with laparoscopic myomectomy.

Exclusion Criteria:

1. combining with ovarian disease or ovarian surgery.

2. preoperative Athens Insomnia Scale (AIS) score = 4 points

3. chronic use of sedative, hypnotic, psychotropic drugs.

4. recent night shift, cross-time zone, irregular life routine.

5. suffering from mental illness or hearing, visual impairment, and existing sleep apnea syndrome.

6. patients withdraw, or were unable to complete the trial after surgery.

7. lossed bleeding volume more than 500 ml during surgery.

8. performed procedure time exceeded 2 h.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Other:
• morning surgery
31 patients will be operated on between 8:00 and 12:00 in the morning.
• afternoon surgery
31 patients will be operated on between 14:00 and 18:00 in the afternoon.

Locations

Country	Name	City	State
China	General hospital of Ningxia medical university	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative sleep disturbances by Athens Insomnia Scale	Postoperative sleep disturbances were defined as the total score of Athens Insomnia Scale more than 6.; The incidence of postoperative sleep disturbances was defined as the percentage of the population with a score greater than 6	1 day after the operation
Primary	The sleep time by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery	The sleep time: was defined as the total time of BIS values less than 80 during monitoring.	1 day after the operation
Primary	The sleep efficiency by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery	The sleep efficiency: was defined as the ratio of a sleeping time over monitoring time.	1 day after the operation
Primary	The sleep quality by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery	The sleep quality: was assessed by the area under curve of BIS (BIS-AUC). The BIS-AUC was calculate using the trapezoidal rule, which used trapezium to approximate the region under a curve and calculate its area (GraphPad Prism Version 5.01; San Diego, California). The smaller BIS-AUC was the better sleep quality.	1 day after the operation
Secondary	Postoperative recovery Post-operative Quality Recovery Scale(PQRS)	Postoperative Quality Recovery Scale includes five parts: physiological functions (blood pressure, heart rate, temperature, ventilation rate, maintenance of oxygen saturation, airway maintenance, agitation, consciousness, response), Nociceptive (pain, nausea), emotional (depression, anxious), activities of daily living (ability to stand, walk, eat, dress), cognitive function (orientation, digits forward, digits backward, word list, word generation). According to the recovery situation: the physiological function is divided into three levels (3 points: acceptable, 2: abnormality, 1: extreme abnormality), nociceptive, emotional change according to the degree of Likert 5 scored (5: very satisfactory, 4: satisfactory, 3: general, 2: not satisfied, 1: very dissatisfied), and the activities of daily living are equally divided into three levels (3: easy, 2: difficulty, 1: it can't be done completely), when cognitive function score reaches the preoperative baseline level,it means recovery.	1 day before surgery (T0), 30 minutes after end of anesthesia (T1), and 1 day after surgery (T2)
Secondary	The biochemical indicators	The levels of melatonin (MT), cortisol, and glulcose in the blood were measured separately by ELISA at 6:00am 1 day before and 1 day after surgery.	6am one day before and one day after the surgery